Efficacy of a Telehealth Delivered Group Lifestyle Balance for People Post Stroke (tGLB-CVA) (tGLB-CVA)

January 19, 2026 updated by: Baylor Research Institute

Efficacy of an Evidence-based Telehealth-delivered Weight-loss Intervention to Enhance Access and Reach Underserved Groups After Stroke

Investigators will conduct a randomized controlled trial (RCT) to assess intervention efficacy of telehealth delivery of the GLB-CVA (tGLB-CVA) compared to a 6-month wait-list control (WLC) in partnership with a diverse group of patient partners and peer mentors.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
94

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75204
        • Recruiting
        • Baylor Scott & White Research Institute
        • Principal Investigator:
          • Evan E McShan, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Body Mass Index ≥25
  • All types of stroke
  • Able to Participate in Physical Activity
  • ≥12 months post first stroke
  • Have internet, phone, or computer access, or be willing to use one provided by the study team

Exclusion Criteria:

  • Contraindications for physical activity
  • Low Cognitive Function
  • Residing in hospital, acute rehab, skilled nursing facility
  • Not fluent in the English language
  • Pre-existing eating disorder
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Wait List Control (WLC)
Participants randomized to the wait list control (WLC) will begin the telehealth Group Lifestyle Balance for People post stroke (tGLB-CVA) intervention 6 months after enrolling into the study and completing a baseline assessment.
Experimental: Telehealth Group LIfestyle Balance for People with Stroke (tGLB-CVA)
The telehealth Group Lifestyle Balance for People post stroke (tGLB-CVA) is a one-year program with 22 sessions. The tGLB-CVA is a modification of the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) developed by the University of Pittsburgh Diabetes Prevention Support Center (DPSC). It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions. The goal of the tGLB-CVA program is to help the participant achieve and maintain a 5-7% weight-loss through healthy eating and physical activity.
Behavioral: Group Lifestyle Balance for People Post Stroke (GLB-CVA)
12-month healthy lifestyle and weight loss program modified from the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Body Weight
Time Frame: Baseline, 3, 6, 9, 12, 18 month
Body weight (lbs) will be captured via self-weighing using provided BodyTrace Smart Scale, which includes cellular connectivity so weight will be sent directly to the research team. The scales have demonstrated good concordance rates with self-weighing in previous research. Scales will be setup by the research team before being mailed to participants with instructions.
Baseline, 3, 6, 9, 12, 18 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Circumference
Time Frame: Baseline, 3, 6, 9, 12, 18 month
Waist and hip circumference (centimeters) will be collected from a local Quest Diagnostics
Baseline, 3, 6, 9, 12, 18 month
Height
Time Frame: Baseline, 3, 6, 9, 12, 18 month
Height (inches) will be collected from a local Quest Diagnostics
Baseline, 3, 6, 9, 12, 18 month
Body Mass Index (BMI)
Time Frame: Baseline, 3, 6, 9, 12, 18 month
Body Mass Index (BMI, kg/m^2) will be calculated from height and weight from a local Quest Diagnostics
Baseline, 3, 6, 9, 12, 18 month
Blood pressure
Time Frame: Baseline, 3, 6, 9, 12, 18 month
Blood Pressure (mmHg, diastolic and systolic) will be collected at a local Quest Diagnostics
Baseline, 3, 6, 9, 12, 18 month
Blood Sugar, Hemoglobin A1c (HbA1c)
Time Frame: Baseline, 3, 6, 9, 12, 18 month
Fasting venous sample will be obtained for Hemoglobin A1c (HbA1c) at a local Quest Diagnostics and recorded as a parentage.
Baseline, 3, 6, 9, 12, 18 month
Blood Glucose
Time Frame: Baseline, 3, 6, 9, 12, 18 month
Fasting venous sample will be obtained for blood glucose (mg/dL) at a local Quest Diagnostics.
Baseline, 3, 6, 9, 12, 18 month
High Density Lipoprotein (HDL) cholesterol
Time Frame: Baseline, 3, 6, 9, 12, 18 month
Fasting venous sample will be obtained for High Density Lipoprotein (HDL, mg/dL) cholesterol at a local Quest Diagnostics
Baseline, 3, 6, 9, 12, 18 month
Low Density Lipoprotein (LDL) cholesterol
Time Frame: Baseline, 3, 6, 9, 12, 18 month
Fasting venous sample will be obtained for Low Density Lipoprotein (LDL, mg/dL) cholesterol at a local Quest Diagnostics
Baseline, 3, 6, 9, 12, 18 month
Fasting venous sample
Time Frame: Baseline, 3, 6, 9, 12, 18 month
Fasting venous sample will be obtained for triglyceride level (mg/dL) at a local Quest Diagnostics
Baseline, 3, 6, 9, 12, 18 month
8-year Diabetes Risk
Time Frame: Baseline, 3, 6, 9, 12, 18 month
The Framingham Heart Study diabetes risk score will be calculated by combining age, gender, fasting glucose, body mass index, HDL cholesterol and triglyceride levels, blood pressure, and parental history of diabetes. Risk score calculator and regression model are free and used in GLB weight-loss trials
Baseline, 3, 6, 9, 12, 18 month
Metabolic Syndrome Severity Score
Time Frame: Baseline, 3, 6, 9, 12, 18 month
Metabolic Syndrome is a cluster of cardiovascular risk factors that include large waist circumference, high body mass index [BMI]), high blood pressure, high triglycerides, low high density lipoprotein (HDL) cholesterol and high fasting blood sugar (HBA1c). The score is calculated by combining these risk factors into a calculator. Individuals who have ≥3 of these risk factors have metabolic syndrome, placing them at greater risk of developing heart disease and diabetes. Risk scores below 0 indicate a lower degree of metabolic syndrome risk than the average US adult; scores above 0 are associated with greater risk for disease. A score of 1 indicates risk is higher than 84.1% of US adults and a score of 2 is higher than 97.7% of US adults. Z scores are calculated for BMI and waist circumference.
Baseline, 3, 6, 9, 12, 18 month
Behavioral Risk Factor Surveillance System (BRFSS)
Time Frame: Baseline, 3, 6, 9, 12, 18 month
The Behavioral Risk Factor Surveillance System (BRFSS) is a state-based system of health surveys that collects information on health risk behaviors, preventative health practices, and health care access primarily related to chronic disease and injury. Investigators will use the two subscales of Healthy Eating and Physical Activity from the 2017 version of the BRFSS. It consists of 14 items.
Baseline, 3, 6, 9, 12, 18 month
Substance Use
Time Frame: Baseline, 12, 18 month
Substance use will be assessed using a brief survey of tobacco use (cigarettes, chewing tobacco), drug use (illicit or non-prescription drugs), and alcohol use.
Baseline, 12, 18 month
Neighborhood Environment Walkability Scale (NEWS)
Time Frame: Baseline, 3, 6, 9, 12, 18 month
Neighborhood Environment Walkability Scale (NEWS) assesses participants' perception of neighborhood features related to physical activity and grocery shopping, including residential density, land use mix (including both indices of proximity and accessibility), street connectivity, infrastructure for walking/cycling, neighborhood aesthetics, traffic and crime safety, and neighborhood satisfaction. Scores provide insight into environmental barriers faced, are sensitive to behavior change, and can be used as a covariate for weight-loss. Scores are calculated in time to walk to local amenities (minutes) as well as Likert Scale from 1 (strongly disagree) to 4 (strongly agree) to ease of access to local amenities. Higher scores on the Likert Scale and lower scores in time suggest greater walkability.
Baseline, 3, 6, 9, 12, 18 month
Quality of Life
Time Frame: Baseline, 3, 6, 9, 12, 18 month
Quality of life (QOL) will be assessed using the Stroke Impact Scale (SIS), which assesses 8 dimensions of health-related quality of life specific to people post stroke including subscales (using a 5pt Likert scale) assessing strength, memory and thinking, emotion, communication, activities of daily living, mobility, hand function, and participation/role function. Higher scores represent greater quality of life.
Baseline, 3, 6, 9, 12, 18 month
Self-Rated Abilities for Health Practice
Time Frame: Baseline, 3, 6, 9, 12, 18 month
Measure includes 28 items that assess health practices among people with disabilities and yields a total Health Practices Score plus 4 subscale scores regarding Exercise, Nutrition, Health Practices, and Psychological Well Being. Items are rated on a 5-point scale from 0 'not at all' to 4 'completely.' Scores range from 0-28 with higher scores indicating higher exercise self-efficacy.
Baseline, 3, 6, 9, 12, 18 month
Social Support for Healthy Eating (SSEH)
Time Frame: Baseline, 3, 6, 9, 12, 18 month
The Social Support for Healthy Eating (SSEH) scale is a 10-item self-report questionnaire assessing the frequency of support received from others for healthy eating habits over the past 3 months on scale from 1 (none) to 5 (very often). It is comprised of a five-item Encouragement and a five-item Discouragement subscale. Family and friend support is measured separately. Higher scores represent greater support.
Baseline, 3, 6, 9, 12, 18 month
Social Support for Physical Activity (SSPA)
Time Frame: Baseline, 3, 6, 9, 12, 18 month
The Social Support for Physical Activity (SSPA) scale is a 13-item self-report questionnaire assessing the frequency of support received from others for engaging in physical activity over the past 3 months on scale from 1 (none) to 5 (very often). It is comprised of a 10-item Participation and a three-item Rewards and Punishments subscale. Family and friend support is measured separately.
Baseline, 3, 6, 9, 12, 18 month
Care Partner Healthy Lifestyle Support Tool
Time Frame: Baseline, 3, 6, 9, 12, 18 month
The Care Partner Healthy Lifestyle Support Tool was designed by researchers at BSWRI to measure how much care partner support was provided to participants during the healthy lifestyle intervention. Questions use a 4-point Likert Scale from "never" to "always", with higher scores representing higher support.
Baseline, 3, 6, 9, 12, 18 month
Exit Survey & Interview
Time Frame: 12 or 18 month
Participants will be asked to complete Exit Survey and Focus Group at the 12 or 18-month assessment to provide experience in, and satisfaction with, the telehealth Group Lifestyle Balance for people post stroke (tGLB-CVA) intervention and suggestions for improvement. The focus group questions will focus on their experience, barriers and facilitators to behavior change, and engagement in the program
12 or 18 month
Telehealth Usability and Satisfaction
Time Frame: 6, 12, 18 month
The Telehealth Usability and Satisfaction Scale is a validated assessment that measures 5 usability factors of telehealth (usefulness, ease of use, effectiveness, reliability, and satisfaction). 9 items are scored on level of agreement from 1-7, with higher scores indicating greater agreement. All subscales have good to excellent reliability (α=.79-.92).
6, 12, 18 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baylor Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Disability, Independent Living, and Rehabilitation Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 7, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BSW IRB# 024-414

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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